Initial Review Process

All research proposals that meet the criteria for full IRB approval will be reviewed by three individuals:

• Primary Reviewer (usually a physician member of the IRB)
• Lay Reviewer (non-physician member of the IRB)
• Legal Counsel

1. Criteria for IRB Approval of Research. In order to approve any proposed research to be conducted at Bridgeport Hospital, the IRB shall determine that all of the following requirements are satisfied:
   1. Patient safety and rights are maintained.
   2. Risks to subjects are minimized.
   3. Risks to subjects are reasonable in relation to anticipated benefits.
   4. Importance of knowledge expected to result.
   5. Selection of subjects is equitable.
   6. Informed consent will be sought from a prospective subject or the subject’s legally authorized representative, in accordance with, and to the extent required by 45 CFR 46.116.
   7. Informed consent will be appropriately documented, in accordance with and to the extent required by 45 CFR 46.117.
   8. When appropriate, the research plan makes adequate provision for monitoring the data collected to ensure the safety of subjects.
   9. When appropriate, there are adequate provisions to protect the privacy of subjects and to maintain the confidentiality of data.
   10. When some or all of the subjects are likely to be vulnerable to coercion or undue influence, such as children, prisoners, pregnant women, mentally disabled persons, or economically or educationally disadvantaged persons, additional safeguards have been included in the study to protect the rights and welfare of these subjects.
   11. In order to protect against financial conflicts of interest or perceived conflicts of interest, all principal investigators must complete a conflict of interest form at the time of initial protocol submission and with each reapproval request.
   12. In addition, if the research study involves an investigational new drug or a significant risk device, the additional requirements set forth in the federal regulations 21 CFR 312 - Investigational New Drug (IND) Applications must be satisfied. http://www.access.gpo.gov/nara/cfr/waisidx_99/21cfr312_99.html